Label: CHEST CONGESTION RELIEF- guaifenesin liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 12, 2021

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients

    Guaifenesin 100 mg

  • PURPOSE

    Purpose

    Expectorant

  • INDICATIONS & USAGE

    Uses

    helps lossen phlegm (mucus) and thin bronchial secretions to make coughs more productive

  • WARNINGS

    Warnings

    Do not use if you ever had an allergic reaction to any of the indregients in this product

    Ask a doctor before use if you have

    • cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Stop use and ask a doctor if cough lasts more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health professional before use. 

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Do not take more than 6 doses in a 24 hour period
    • Do not exceed recommended dose
     Adults and children 12 years and over 2 to 4 teaspoonfuls every 4 hours
     children under 12 years ask a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients. Artificial and natural cherry flavor, citric acid, FD&C Red #40, menthol, methylparaben, propylene glycol, propylparaben water, sodium citrate, sucralose

  • QUESTIONS

    Questions or comments? 1-800-645-2158

  • PRINCIPAL DISPLAY PANEL

    chestcongest

  • INGREDIENTS AND APPEARANCE
    CHEST CONGESTION RELIEF 
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1314
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    water (UNII: 059QF0KO0R)  
    sodium citrate (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1314-85473 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/01/2020
    Labeler - RUGBY LABORATORIES (079246066)